Prescription drug · ANDA
Desmopressin Acetate NDC 60687-721
Desmopressin acetate .1 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-721-21 | 60687072121 | 30 BLISTER PACK in 1 CARTON (60687-721-21) / 1 TABLET in 1 BLISTER PACK (60687-721-11)Marketed from Feb 16, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Desmopressin Acetate
- Generic name (nonproprietary)
- desmopressin acetate
- Active ingredients
- Desmopressin acetate — .1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077414
- Marketing start
- Listing expires
- Other FDA classes
- Increased Coagulation Factor VIII Activity (Physiologic effect)Increased Coagulation Factor VIII Concentration (Physiologic effect)Vasopressins (Chemical structure)
- Identifiers
- Product ID 60687-721_437dc780-8fd1-6205-e063-6394a90a19dbSPL ID 437dc780-8fd1-6205-e063-6394a90a19dbSPL set ID 0d447b48-3f4b-430e-9e68-d8b9401c002eRxCUI 833008, 849515UNII XB13HYU18U
- Pharmacologic class
- Factor VIII Activator; Vasopressin Analog
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460687072121followed by a unit qualifier and the quantityPackage 60687-0721-21. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Central Diabetes Insipidus Desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. Primary Nocturnal Enuresis Desmopre…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077414
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Desmopressin Acetate | Desmopressin acetate .2 mg/1 | TabletOral | Apotex Corp. | 60505-0258 |
| Desmopressin Acetate | Desmopressin acetate trihydrate .1 mg/1 | TabletOral | Apotex Corp. | 60505-0257 |
| Desmopressin Acetate | Desmopressin acetate .2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3257 |
| Desmopressin Acetate | Desmopressin acetate .1 mg/1 | TabletOral | BluePoint Laboratories | 68001-574 |
| Desmopressin Acetate | Desmopressin acetate .2 mg/1 | TabletOral | BluePoint Laboratories | 68001-575 |
| Desmopressin Acetate | Desmopressin acetate .2 mg/1 | TabletOral | American Health Packaging | 60687-732 |